Month: July 2020

FDA Advisory No. 2020-1406 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. BUSTOSIA Creamy Peanut Butter
  2. COSMETIC CENTRE Sodium Ascorbate Active Alkaline-C 500 mg Capsules
  3. MARSHAL’S FARM Pure Honey
  4. DAVID’S FAITH Insulin Wine
  5. DAVID’S FAITH Insulin Tea

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1406

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1406 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1405 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. TRADITIONAL MEDICINALS Organic Echinacea Plus Elderberry Herbal Supplement, Tea Bags
  2. SIS Raw Sugar Cubes
  3. SIS White Sugar Cubes
  4. LA PERRUCHE Pure Cane
  5. SUGAR CUBES Centrifugal

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1405

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1405 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1401 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. MCCHEF White Lihia
  2. MIKASAN Choco Flakes
  3. GOLD EAGLE Nutritious Cornick
  4. JOCYL’S Crispy Shrimp
  5. JAC CAN FOOD TRADING Crispy Mushroom Chocharon

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1401

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1401 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1400 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. CRV Ube Powder (Purple Yam Powder)
  2. KM’S ORGANICS Organic Coconut Aminos
  3. RESTOHUB Bread Flour
  4. PEP-D Coconut Aminos
  5. SPRINGMADE Palm Oil

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1400

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1400 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1399 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. REALFOOD Activated Pili Nuts from Naga
  2. REALFOOD Organic Palawan Cashew
  3. REALFOOD Organic Walnuts from US
  4. REALFOOD Raw Brazil Nuts
  5. REALFOOD Pistachios in Shell from US

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1399

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1399 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1398 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements:

  1. 24 ALKA-C Sodium Ascorbate
  2. NATURE’S KIND MIRACLE MALUNGGAY Moringa oleifera Capsules
  3. NATURE’S KIND Natural Lung Support Capsules
  4. NATURE’S KIND Blood Sugar Support Capsules
  5. NATURE’S KIND Natural Joint Support Capsules

The FDA verified through online monitoring that the abovementioned food supplements are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1398

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1398 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2020-1397 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. SILT Cacao Pancake Mix
  2. SILT Gravy Mix
  3. SILT Original Pancake Mix
  4. THE SEXY CHEF Keto Pancake Mix
  5. AMORES Pancake Mix

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1397

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1397 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1388 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Play Quest Natural Latex Rubber Condom”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-1388

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1388 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Play Quest Natural Latex Rubber Condom”

FDA Advisory No. 2020-1387 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “Pediatric Urine Collector”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not notified and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-1387

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1387 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “Pediatric Urine Collector”

FDA Advisory No. 2020-1386 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Natural Latex Rubber Condoms (0.03)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned advisory or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1386

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1386 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “PQ Natural Latex Rubber Condoms (0.03)”

FDA Advisory No. 2020-1379 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “NATURAL LATEX RUBBER CONDOM (IN FOREIGN CHARACTERS)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1379

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1379 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “NATURAL LATEX RUBBER CONDOM (IN FOREIGN CHARACTERS)”

FDA Advisory No. 2020-1382 || Voluntary Recall of “Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP”

The Food and Drug Administration (FDA) warns all healthcare professional and the general public on the voluntary recall of Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP with MDR No. 04161, manufactured by CareFusion DR 203 Ltd. and distributed by Lifelink Inc.:

Product Name Product Code Lot Number
Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP DJ4011X 0001303256
0001303257

Lifelink Inc. received a letter from Becton, Dickinson and Company (BD) informing that the product code and lot number combination of the affected medical device product listed in the table above may be at risk of having some packaging pouches that was not sealed properly. When used, the improperly sealed medical device product may introduce contaminants or disease vectors into the patient’s body which may lead to contamination or infection. At the present, there have been no reported health claims associated to the affected medical device product.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the medical device.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1382

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1382 || Voluntary Recall of “Jamshidi™ Bone Marrow Biopsy/Aspiration Needle, with Luer-Lock Adapter 11GX4 ASP”

DRAFTS FOR COMMENTS OF ADMINISTRATIVE ORDER “ADOPTION OF THE COLLABORATIVE PROCEDURE FOR THE ACCELERATED REGISTRATION OF WORLD HEALTH ORGANIZATION (WHO) – PREQUALIFIED DRUG PRODUCTS AND VACCINES”

Please see the following drafts for industry comments:

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 14 August 2020.

/ In Draft for Comments / By Administrator / Comments Off on DRAFTS FOR COMMENTS OF ADMINISTRATIVE ORDER “ADOPTION OF THE COLLABORATIVE PROCEDURE FOR THE ACCELERATED REGISTRATION OF WORLD HEALTH ORGANIZATION (WHO) – PREQUALIFIED DRUG PRODUCTS AND VACCINES”

FDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)

As of  today, 30 July 2020, FDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No. 2020-1385 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. INFUSION SET WITH NEEDLE – 0.6mm
  2. INFUSION SET WITH NEEDLE – 0.55mm
  3. INFUSION SETS FOR SINGLE-USE WITH NEEDLES

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Product Notification Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1385

FDA Advisory No. 2020-1384 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.  

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1384

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1384 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

FDA Advisory No. 2020-1383 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.      

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1383

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1383 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

FDA Advisory No. 2020-1381 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ELECTRONIC THERMOMETER TD138”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “ELECTRONIC THERMOMETER TD138”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1381

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1381 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ELECTRONIC THERMOMETER TD138”

FDA Advisory No. 2020-1378 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. TRADITIONAL MEDICINALS Organic Tulsi with Ginger Herbal Supplement, Tea Bags
  2. TRADITIONAL MEDICINALS Gypsy Cold Care Herbal Supplement, Tea Bags
  3. TRADITIONAL MEDICINALS Organic Stress Ease Cinnamon Herbal Supplement, Tea Bags
  4. TRADITIONAL MEDICINALS Healthy Cycle Herbal Supplement, Tea Bags
  5. TRADITIONAL MEDICINALS Organic Rose Hips with Hibiscus Herbal Supplement, Tea Bags

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1378

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1378 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1377 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. TRADITIONAL MEDICINALS Organic EveryDay Detox Lemon Herbal Supplement, Tea Bags
  2. TRADITIONAL MEDICINALS Yellow Pau d’ Arco Herbal Supplement, Tea Bags
  3. TRADITIONAL MEDICINALS Organic Weightless Cranberry Herbal Supplement, Tea Bags
  4. TRADITIONAL MEDICINALS Organic Mother’s Milk Shatavari Cardamom Herbal Supplement, Tea Bags
  5. TRADITIONAL MEDICINALS Organic Hawthorn with Hibiscus Herbal Supplement, Tea Bags

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1377

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1377 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1376 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. TRADITIONAL MEDICINALS Seasonal Sampler Herbal Supplement, Tea Bags
  2. TRADITIONAL MEDICINALS Organic Gas Relief Herbal Supplement, Tea Bags
  3. TRADITIONAL MEDICINALS Organic Green Tea Dandelion Herbal Supplement, Tea Bags
  4. TRADITIONAL MEDICINALS Organic Raspberry Leaf Herbal Supplement, Tea Bags
  5. TRADITIONAL MEDICINALS Organic Mother’s Milk Herbal Supplement, Tea Bags

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1376

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1376 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1375 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. FROZEN COLLAGEN 2in1 Whiteningx10Premium Collagen Peptide 9,000mg L-Glutathione 3,000mg
  2. TRADITIONAL MEDICINALS Breathe Easy Herbal Supplement, Tea Bags
  3. TRADITIONAL MEDICINALS Organic Ginger Aid Herbal Supplement, Tea Bags
  4. TRADITIONAL MEDICINALS Organic Green Tea Lemongrass Herbal Supplement, Tea Bags
  5. TRADITIONAL MEDICINALS Organic EveryDay Detox Herbal Supplement, Tea Bags

The FDA verified through online monitoring that the abovementioned food products and food supplement are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1375

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1375 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1360 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. NATURE’S WAY Super Thisilyn Advanced Detox Dietary Supplement
  2. FROZEN DETOX 2 in 1 Detox & Fiberry Dietary Supplement
  3. GFOXX Xseed Antioxidant Juice
  4. BUGNA Batuan Powder
  5. 12 in 1 BUAH MERAH Juice Anti-Oxidant

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

 Attachment:-> FDA Advisory No.2020-1360

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1360 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1359 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplements:

  1. SINTA Haba-Haba Yogurt Sticks
  2. PMS Mangosteen Capuccino Coffee
  3. ALA EH BARAKO Batangas Coffee
  4. SINTA Fruit Popping Candy
  5. WESLSY Milk Powder Stick

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1359

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1359 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1358 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Product and Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consumption of the following unregistered food products and food supplements with unapproved advertisements and promotions:

  1. Maca + American Ginseng Capsules Food Supplement
  2. Spirulina Tablets Food Sipplements
  3. KIVEPLAS w/ Kibizu, 70 Vegetable Enzyme Blends, Placenta Extract, Astaxanthin

The FDA verified through post-marketing surveillance that the abovementioned food product and food supplements are not registered and the Certificate of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Likewise, all claims in the advertisements are false, deceptive, and misleading. As per Administrative Order 2010-0008, no person shall advertise, promote, or use in any sponsorship any food/dietary supplements unless such product is duly registered and approved by the Food and Drug Adminisration.

Since these unregistered food product and food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product or food supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1358

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1358 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Product and Food Supplements:

FDA Advisory No. 2020-1357 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. REALFOOD Tomato Garlic Sauce
  2. THIRD’S WORLD Puttanesca Sauce
  3. THIRD’S WORLD Tuna Pasta Sauce
  4. LORENZO’S SANCTUARY Spiced Vinegar
  5. CHARLIE & ANGUS Fruity Habanero Hot Sauce

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1357

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1357 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1356 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. HEART KEEP Nutritional Supplement Hard Gelatin Capsules
  2. CHARLIE & ANGUS Persian Eggplant & Chickpea Stew
  3. CHARLIE & ANGUS Hummus Classic Chickpea Spread
  4. CHARLIE & ANGUS Persian Style Keema Stew
  5. REALFOOD Vegan Marinara Sauce

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1356

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1356 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1355 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. THE UNBAKERY Coco PB Energy Balls
  2. MANTRA BAR Cinnamon Cacao Natural Nut and Fruit Snack
  3. MANTRA BAR Coffee Natural Nut and Fruit Snack
  4. JEMEL KENT’S Mushroom Square Bars Chili Lime Sesame
  5. JEMEL KENT’S Mushroom Square Bars Superseeds

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1355

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1355 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2020-1336 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements:

  1. DYMATIZE CREATINE MICRONIZED DIETARY SUPPLEMENT
  2. DOCTOR’S BEST ALPHA-LIPOIC ACID 600
  3. INSULEAF INSULIN PLANT HERBAL CAPSULE
  4. SPRING VALLEY CHEWABLE PAPAYA ENZYME COMPLEX DIETARY SUPPLEMENT – DIGESTIVE HEALTH
  5. SKINNYMINT 14 DAY TEATOX

The FDA verified through online monitoring or post-marketing surveillance that the above mentioned food supplements are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDAwebsite accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, kindly email us through [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1336

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1336 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2020-1335 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. LIFE EXTENSION FAST ACTING JOINT FORMULA DIETARY SUPPLEMENT
  2. NATROL GUARANA – ENERGY SUPPORT DIETARY SUPPLEMENT
  3. NATROL SOY ISOFLAVONES –MENOPAUSE RELIEF DIETARY SUPPLEMENT
  4. NATROL GINKGO BILOBA – BRAIN HEALTH DIETARY SUPPLEMENT
  5. NATROL CINNAMON CHROMIUM & BIOTIN – BLOOD SUGAR HEALTH DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the above mentioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product/food supplements is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered food product/food supplement, kindly email us through [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1335

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1335 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements: